A New Glucose Meter With Alternative Site Testing

Diabetes Mellitus Clinical Trial

Official title:

Clinical Evaluation of the Apollo Blood Glucose Monitoring System With Alternative Site Testing [Commercial Name is CONTOUR® USB]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00797212
• Other study ID #: CTD-2008-19
• Status: Completed
• Phase: N/A
• First received: November 24, 2008
• Last updated: January 29, 2016
• Start date: November 2008
• Est. completion date: November 2008

Study information

• Verified date: January 2016
• Source: Ascensia Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of the study was to evaluate the performance of the blood glucose monitoring system when used with samples taken from the palm and forearm for alternative site testing (AST).

Description:

The blood glucose monitoring system may be used for alternative site testing. The blood glucose results obtained by subjects with samples taken from the palm and forearm were compared with fingerstick capillary blood glucose results obtained from subjects by an HCP. Product labeling was evaluated for comprehension of performing alternative site testing as well as for additional meter features. User feedback about the system and its features was obtained.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Have type 1 or type 2 diabetes

• Be >18<76 years of age at time of consent, with approximately 50% (+10%) being less than 55 years of age

• Be willing to complete all study procedures

• Be routinely testing their blood sugar at home (at least once per day)

• Be able to speak, read, and understand English and understand the Informed Consent document

• Be able to read the labeling instructions

Exclusion Criteria:

• Minors <18 years of age and adults >75 years of age

• Pregnancy

• Physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the BGMS

• Disorders in the fingertip lancing areas

• Acute or chronic infections, particularly skin infections

• Infection with a blood borne pathogen

• Taking prescription anti-coagulants or having clotting problems that may prolong bleeding. Taking aspirin daily (81mg or 325 mg) is not reason for exclusion.

• Hemophilia or any other bleeding disorder

• Having a condition which, in the opinion of the Principal Investigator or designee, would put the person at risk or seriously compromise the integrity of the study

• Working for a competitive medical device company

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Apollo Blood Glucose Monitoring System
Subjects with diabetes use a new blood glucose monitoring system with blood taken from the palm and forearm. These blood glucose AST results are compared with results obtained by healthcare professionals (HCPs) from subject fingersticks.

Locations

Country	Name	City	State
United States	Jasper Clinic, Inc.	Kalamazoo	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Ascensia Diabetes Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of AST Results Within +/- 15mg/dL or +/- 20% of Fingerstick (FS)Blood Glucose Results	Performance of the blood glucose monitoring system when the system is used for alternative site testing (AST) with samples from the palm and forearm compared with BGMS fingerstick capillary blood results obtained by an HCP	One hour	No
Secondary	Percentage of Participants Rated as <=3 (Labeling Comprehension)	Study staff rated participants as to their success at performing meter testing. The rating scale was: Successful; Successful after being referred to user instructions; Successful with verbal assistance or review of part of user instructions (Similar to review of a specific function during a Customer Service call.); Unsuccessful (Incorrectly performed part of the testing regimen or required intervention by study staff.)	One hour	No
Secondary	Percentage of Participant Ratings for Overall Testing Experience With This Meter	Subjects completed a questionnaire rating their overall experience with the Apollo Blood Glucose Monitor System (User feedback on the system). The rating scale was 0 (Unacceptable) to 4 (Excellent).	One hour	No